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For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.

VK-3 Verification Kit is a calibration verification kit consisting of the following 5 quality control solutions: Hematocrit and Metabolite QUALICHECK Level 1, S7170 (K150226), Hematocrit and Metabolite QUALICHECK Level 2, S7180 (K150226), Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236). These quality control solutions have been 510(k) cleared (K150226 and K130236) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Hematocrit and Metabolite QUALICHECK quality control solutions are aqueous solutions containing organic buffer, acid, salts, metabolites, and a preservative. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-4 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Qualicheck 5+ Level 1, S7730 (K980135), Qualicheck 5+ Level 2, S7740 (K980135), Qualicheck 5+ Level 3, S7750 (K980135), Qualicheck 5+ Level 4, S7760 (K980135). These quality control solutions have been 510(k) cleared (K980135) with an intended use which did not include calibration verification. Production of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-R5 Verification Kit is a calibration kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), Qualicheck 5+, Level 3, S7750, (K980135). These quality control solutions have been 510(k) cleared (K130236 and K980135) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-R7 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), High Metabolite QUALICHECK Level 1, S7570 (K130415). These quality control solutions have been 510(k) cleared (K130236 and K130415) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. The High Metabolite QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, metabolites and a preservative.

VK-Crea Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: AutoCheck6+ Level 1, S7835 (K051928), AutoCheck6+ Level 2, S7845 (K051928), AutoCheck6+ Level 3, S7855 (K051928), Cleaning Met II Solution, S8377 (K051968). These quality control solutions have been 510(k) cleared (K051928) and (K051968) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each level of AutoCheck6+ and one bottle of Cleaning Met II Solution. Each AutoCheck6+ ampoule contains 0.7 mL solution. The Cleaning Met II Solution contains 100 mL solution. The quality control solutions are aqueous solutions containing biological buffers, salts, metabolites, enzyme and a preservative. The AutoCheck6+ solutions also contain dyes and are equilibrated with carbon dioxide and oxygen.

The provided document describes the clearance of several "Verification Kits" as calibration verification materials for in vitro diagnostic use. It establishes substantial equivalence by comparing the new kits to a predicate device (Validate GC1, GC2, GC3, and GC4 Calibration Verification/Linearity Test Sets).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance of the new Verification Kits. Instead, it leverages the previous 510(k) clearances of the individual components within these kits and argues that because the new kits are essentially repackaged and relabeled versions of already cleared products, their performance characteristics are maintained. The acceptance criteria essentially revolve around demonstrating that the new kits are substantially equivalent to the predicate device and that their performance (stability, storage, traceability, and value assignment) is consistent with the cleared individual components.

• Intended Use
• Fundamental Scientific Technology
• Features
• Characteristics | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Intended Use: "For in vitro diagnostic use. ... assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges." (Similar to predicate)
• Fundamental Scientific Technology: All kits are liquid, aqueous solutions, similar to predicate.
• Features: All kits are multi-analyte controls.
• Characteristics: Product Code (JJY), Matrix (Aqueous primarily, predicate has human serum and aqueous), Traceability (IUPAC pH scale, NIST SRM, IFCC, SIGMA, primary analytical standards). Measurands vary but are within the scope of multi-analyte controls. |
  | Stability (Shelf Life):
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Shelf life: 24 months (or 12 months for VK-Crea) as maximum, depending on oldest component. (Predicate: 12 months for all). Document states stability is "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968" (previous clearances of individual components). |
  | Stability (Open Vial):
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Open vial stability: N/A, "shall be used immediately." (Predicate: 12 months). The document states that the open vial stability for the new kits is "not affected by the repackaging" implying that the lack of open vial stability is part of the established performance. |
  | Storage Conditions:
• Maintained from individual components | VK-3, VK-R5, VK-R7, VK-Crea: 2 °C – 8 °C.
  VK-4: 2 °C – 25 °C. (Predicate: 2 °C – 8 °C). Document states storage conditions are "for the most temperature sensitive component" and "documented by reference to K150226, K980135, K130415, K051928 and K051968". |
  | Traceability:
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Traceable to "established international references as defined for the individual components and are unchanged." (Predicate: NIST SRM, primary analytical standards). Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |
  | Value Assignment:
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• "Assigned values for each of the parameters are transferred unchanged from the labeling of the individual components to the Verification Kits." Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a traditional "test set" in the context of device performance in the same way one would for a new clinical diagnostic algorithm. This submission is for an in vitro diagnostic control material that is a repackaging of existing, cleared components.

• Sample Size for Test Set: Not applicable in the conventional sense. The "test" for the new kits primarily involves demonstrating that repackaging does not alter the established performance of the individual components. The performance data for the individual components would have been provided in their respective 510(k) submissions (K150226, K130236, K980135, K130415, K051928, K051968). The current submission relies on references to these previous clearances.
• Data Provenance: The data provenance for the underlying performance of the individual components would be detailed in their original 510(k) submissions. This document implies retrospective reliance on previously cleared data. It does not mention any new prospective studies specific to the repackaged kits, beyond demonstrating that the new packaging/labeling process itself doesn't degrade the product.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. The "ground truth" for calibration verification kits refers to the accurately assigned values for the analytes. This is established through rigorous analytical measurement and traceability to international standards (e.g., NIST SRM, IUPAC pH scale, IFCC, SIGMA), not by expert consensus in clinical interpretation.

4. Adjudication Method for the Test Set

This is not applicable for a calibration verification kit. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human experts are interpreting results and discrepancies need to be resolved. The "truth" for these kits is analytical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used for evaluating the performance of imaging or other diagnostic devices where human interpretation is involved, often in comparison to an AI algorithm. The devices in question are calibration verification kits, which are chemical analytical controls. There is no human "reader" or AI involved in their direct function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The devices are physical chemical control solutions, not software algorithms.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these calibration verification kits is analytical traceability, established through:

• Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM).
• International Standards: Traceability to IUPAC pH scale, IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) standards, and SIGMA standards.
• Primary Analytical Standards: The document mentions "primary analytical standards" for the predicate device, implying similar methodologies for the SE device's components.

These methods involve precise chemical and physical measurements to assign accurate values to the analytes in the control solutions.

8. The Sample Size for the Training Set

This is not applicable. These are physical chemical control materials, not AI algorithms or models that require training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set." The ground truth for the performance parameters of the individual components of these kits was established through analytical methods and traceability as described in point 7, during their original 510(k) clearances.

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The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.

The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated analysis of quality control fluids. The AutoCheck module is designed to work with a quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids in AutoCheck 5+ correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135).

The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules designed to break the top of an ampoule when it is to be used. Furthermore, each ampoule has a bar code containing information on the specific level and lot of the quality control fluid.

Installing an AutoCheck module into an existing ABL700 Series Analyzer includes physically installing the module and loading upgraded software which controls the function of the AutoCheck module. The AutoCheck module comprises an ampoule carrousel carrying 20 ampoules of quality control fluid and further comprises a bar code reader for reading the bar code located on each ampoule. When installed into the ABL700 Series Analyzer, the AutoCheck module automatically performs the quality control of the analyzer. Thus, when a quality control is due, the analyzer warns the user and if the user accepts, the quality control is performed. The software selects the appropriate ampoule, the AutoCheck module opens the ampoule by pressing the cap through the top of the ampoule, the quality control fluid is automatically introduced into the analyzer inlet and the measurements are performed. The upgraded software controls all steps. If required, a manual quality control may be performed as well.

The provided text describes a medical device, the ABL700 with AutoCheck Module, and its 510(k) submission for market clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the statistical metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in such a study report.

The document focuses on:

• Product Description: How the AutoCheck module adds automated quality control functionality to the ABL700 analyzer.
• Intended Use: The parameters measured (pH, pCO2, pO2, etc.) and the types of samples (human arterial/venous and capillary whole blood).
• Technological Characteristics vs. Predicate Device: Stating it's "Similar to the ABL700 Series."
• Substantial Equivalence: Claiming it's substantially equivalent to the existing ABL700 Series (K980130).

The mention of "automated analysis of quality control fluids" is the closest it comes to a performance claim, but no specific performance targets or results are presented.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an attempt to answer based on the available information, noting where data is absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified. The document refers to "automated analysis of quality control fluids" but does not detail a specific test study with a defined sample size of these fluids.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/Not specified. Ground truth for automated quality control measurements on a device would typically be established by comparing against known reference values of the quality control fluids, not expert consensus.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, this is not an MRMC study. The device is an automated blood gas analyzer with an automated quality control module. It does not involve human readers interpreting medical images or data that would be assisted by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, implicitly this device operates in a standalone manner for its quality control function. The AutoCheck module "automatically performs the quality control of the analyzer." However, specific performance metrics for this standalone function are not provided.

7. The type of ground truth used

• Type of Ground Truth: For quality control fluids, the ground truth would typically be the known, certified values of the analytes (pH, pCO2, pO2, etc.) within the quality control solutions themselves. The document mentions "AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids...correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135)," indicating the use of commercial quality control materials with established values.

8. The sample size for the training set

• Sample Size (Training Set): Not specified. The device is an analyzer for blood gases and electrolytes, not an AI/ML algorithm that would typically have a "training set" in the conventional sense of machine learning. The "upgraded software" mentioned controls the automated quality control process, but the document does not describe its development in terms of a training set.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not applicable/Not specified, as this is not a traditional AI/ML training context for which a ground truth for a training set would be established. The "ground truth" for the device's functionality would be the accuracy and precision of its measurements against known standards, including those provided by the quality control fluids.

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The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb, and FHHbF).

ABL735 is an automated pH/Blood Gas/Co-oximetry/Electrolyte/Metabolite Analyzer that is 44cm X 70cm X 50cm (HWD) and weighs 30kg. It measures on whole blood in approximately 60 seconds.

The provided text is a 510(k) summary for the Radiometer ABL735 analyzer, which details its intended use and establishes substantial equivalence to predicate devices. However, it does not include information about acceptance criteria, efficacy studies, sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

The document is a regulatory submission focused on demonstrating that a new device is "substantially equivalent" to already legally marketed devices. This process often relies on showing similar technological characteristics and intended use, rather than conducting new, extensive efficacy studies with specific acceptance criteria that would be reported in detail in such a summary.

If such studies were performed to establish the device's performance, the details you're asking for would typically be found in a separate study report or a more comprehensive performance evaluation section, which is not present here.

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NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO2 pO2 ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.

NPT7 Series is a stand-alone blood gas analyzer

This FDA 510(k) clearance letter dated January 6, 1999, for the Radiometer America Inc. NPT7 Series Analyzer with DRI-TEK Cartridge, does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory aspects such as:

• Trade Name: NPT7 Series Analyzer with DRI-TEK Cartridge
• Product Codes and Regulatory Classifications: CHL, JHP, CGA, CGZ, CEM, JGS, & GKF (Class II), KHP (Class I)
• Date Received and Dated: August 12, 1998, and August 20, 1998
• Substantial Equivalence Determination: Based on its comparison to predicate devices marketed before May 28, 1976.
• General Controls Provisions of the Act: Mentioning annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Contact Information for Further Assistance: Regarding labeling, promotion/advertising, and general responsibilities.
• Indications for Use: Measures pH, pCO2, pO2, and Co-oximetry parameters on human arterial/venous and capillary whole blood, intended for use in laboratory and point-of-care testing by minimally trained personnel, and designed for stationary use as well as in moving vehicles and aircraft.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

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ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.

ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.

This is an in vitro diagnostic device, not one for which the requested information (like expert readers, adjudication methods, multi-reader multi-case studies, or ground truth types like pathology/outcomes data) is typically relevant or provided in a 510(k) summary. The document describes a blood gas analyzer, and its performance is typically evaluated against reference methods or established predicate devices, not through human interpretation of images or signals.

Therefore, much of the requested information cannot be extracted from the provided text because it doesn't pertain to this type of medical device submission.

However, I can provide what is relevant and available:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (HSC130) is a 510(k) summary for the Radiometer America Inc. ABL700 Series. It states that the device is "substantially equivalent" to predicate devices, namely the ABL625 (K962334) and ABL555 (K973367). In 510(k) submissions for in vitro diagnostic (IVD) devices like blood gas analyzers, "acceptance criteria" and "reported device performance" are typically demonstrated through comparisons to these predicate devices or established reference methods. However, the specific numerical performance data or acceptance criteria are not detailed in this summary. The summary focuses on technological characteristics and intended use.

Therefore, an explicit table of acceptance criteria and reported device performance from the provided document cannot be constructed. The statement of substantial equivalence implies that the device performs comparably to the predicate devices and meets a level of performance acceptable for its intended use, but the detailed metrics are not included in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary. Performance studies for IVD devices typically involve testing patient samples, but details on the source (e.g., country of origin) or whether it was retrospective/prospective are not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not relevant for this type of in vitro diagnostic device. The "ground truth" for a blood gas analyzer's measurements would typically be established by comparing its results to a well-calibrated reference method or accepted laboratory standard, not through expert consensus on images or interpretations.

4. Adjudication method for the test set:

Not relevant for this type of in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not applicable here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is an automated blood gas analyzer, not an AI-assisted diagnostic tool that aids human readers in interpreting images or data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, the ABL700 Series is described as a "stand-alone blood gas analyzer." Its performance evaluation would inherently be "standalone" in this context, meaning the device itself produces the measurement results without human interpretation being part of the primary diagnostic output being evaluated.

7. The type of ground truth used:

The type of "ground truth" for a blood gas analyzer would be established by:

• Reference methods: Comparison of the ABL700's measurements (pH, pCO2, pO2, etc.) against established, highly accurate reference laboratory methods.
• Predicate device comparison: Performance comparison against the ABL625 and ABL555 predicate devices, implying that the predicate devices' established performance serves as a benchmark for "truth."

This exact detail is not explicitly stated as "ground truth" in the summary but is implied by the nature of device testing.

8. The sample size for the training set:

Not applicable or specified. Blood gas analyzers are typically calibrated using known standards and reagents, not "trained" on a data set in the same way machine learning algorithms are.

9. How the ground truth for the training set was established:

Not applicable for this type of device. Calibration of the device is typically done using standardized calibrants with known values, not through establishing "ground truth" for a training set in the context of machine learning.

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Qualicheck5+ is a liquid, four ampoule quality control system, for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate.

Qualicheck5+ is a four level quality control system consisting of part numbers S7730, S7740, S7750 and S7760. Each level consists of 30 ampoules per box.

The provided text is a 510(k) summary for the Qualicheck™5+ quality control system. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing of a new algorithm or system. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided document.

Here's why and what information is available:

The document explicitly states:

• "Qualicheck5 + is technologically similar to Multicheck. DEVICE:"
• "EQUIVALENCE: Qualicheck5+ is substantially equivalent in features and characteristics to the current Multicheck (K961355) marketed by Radiometer America Inc. The major difference is the addition of the chloride (cCL) analyte."

This indicates that the submission is primarily focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed performance study with specific acceptance criteria as you would see for a novel algorithmic device.

The FDA's response confirms they reviewed the 510(k) notification and determined the device is "substantially equivalent." This determination is typically based on comparing the new device's design, materials, and intended use to a predicate device, and often includes bench testing to ensure the new device performs as expected, but the details of such testing (e.g., specific acceptance criteria, sample sizes, ground truth) are usually not included in this type of summary document.

In summary, the provided text does not contain the information required to complete your request for acceptance criteria and a study proving those criteria are met for an AI/algorithmic device.

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ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, Hct, and the option of one of the following parameters: ClT or Ca2 or glucose or lactate.

ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.

The provided text is a 510(k) summary for the ABL555 Blood Gas, Electrolyte, and Metabolite Measuring System. It describes the device and its intended use but does not contain information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the substantial equivalence of the ABL555 to previously marketed devices (ABL555, EML105, i-STAT Model 100, and Corning 348) and the regulatory approval process.

The relevant sections of the input text explicitly state that the ABL555 is technologically similar to the current version ABL555 and is substantially equivalent in features and characteristics to the current ABL555 marketed by Radiometer America Inc. (K973367). The major difference is the addition of the lactate and hematocrit. This implies that the device is being approved based on its similarity to an already approved device, rather than through new performance studies detailing acceptance criteria and outcomes.

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ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, and glucose on whole blood.

ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.

The provided text describes the Radiometer America Inc. ABL555, an automated blood gas, electrolyte, and metabolite analyzer. However, it does not contain specific acceptance criteria, study data, or details about the methodology used to prove the device meets any such criteria. The document is a 510(k) summary for premarket notification, primarily focused on establishing substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify any acceptance criteria (e.g., accuracy, precision targets) nor does it report specific device performance metrics against such criteria. It states that the ABL555 is "substantially equivalent in features and characteristics to the current ABL505."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not mention any specific test set, its sample size, or the provenance of any data used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. There is no mention of a test set, ground truth establishment, or experts involved in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No information on a test set or adjudication methods is present.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Implied, but details are absent. The ABL555 is described as an "automated blood gas, electrolyte and metabolite analyzer" and a "stand-alone" device. This implies its performance is assessed independently, without human-in-the-loop performance as a primary measure. However, no specific "standalone" study details, methodology, or results are provided in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. The document does not describe how any ground truth was established for performance evaluation. For a blood gas analyzer, ground truth would typically come from reference methods or established calibration standards, but this is not detailed here.

8. The sample size for the training set

• Not applicable / Cannot be provided. This device, as described, is a physical instrument for measuring analytes, not a machine learning algorithm that requires a "training set" in the conventional AI sense. If it contains internal algorithms for calibration or data processing, the details of those are not provided, nor is the concept of a "training set" used.

9. How the ground truth for the training set was established

• Not applicable / Cannot be provided. As above, the concept of a "training set" for an AI model is not mentioned or relevant to the description of this device in the document.

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Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.

Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses. Available in multiple sizes and product versions.

This document is a 510(k) summary for a medical device called "PICO Arterial Blood Sampler." It focuses on establishing substantial equivalence to a predicate device ("Smooth ETM") and does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined.

The document is a regulatory submission for premarket notification, designed to show that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically include performance studies against pre-defined acceptance criteria for clinical efficacy or accuracy in the way that, for example, an AI diagnostic device would.

Therefore, I cannot provide the requested information from this input as it does not contain the details about:

1. A table of acceptance criteria and reported device performance: This document describes the intended use and technological characteristics as similar to the predicate, but doesn't quantify performance metrics or acceptance criteria for a study.
2. Sample size used for the test set and data provenance: No performance study is described.
3. Number of experts used to establish ground truth & qualifications: N/A, no ground truth needed for this type of submission.
4. Adjudication method: N/A.
5. MRMC comparative effectiveness study: N/A.
6. Standalone performance study: The device is a physical sampler, not an algorithm, so "standalone performance" in the AI sense isn't applicable.
7. Type of ground truth used: N/A.
8. Sample size for the training set: N/A, not applicable to this physical device.
9. How ground truth for the training set was established: N/A.

The content of this document is limited to demonstrating substantial equivalence for a physical medical device (an arterial blood sampler) based on its features, intended use, and technological characteristics compared to a previously cleared device. It is not an evaluation of clinical performance against specific metrics or expert-validated ground truth data.

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EML105 is a stand alone, electrolyte metabolite analyzer that measures Na , K+, Ca2+, CI, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry.

EML105 is an automated electrolyte metabolite analyzer that is 40 cm x 35 cm x 40 cm (WHD) and weighs 22 kg. It measures on whole blood and urine in approximately 54 seconds.

This document is a 510(k) summary for a medical device called EML105, an electrolyte metabolite analyzer. It describes the device, its intended use, and claims substantial equivalence to a previously marketed device (EML105) and a predicate device (YSI 2300) for the new lactate analyte.

However, the provided text does not contain any information regarding acceptance criteria, study methodologies, device performance data, sample sizes, ground truth establishment, or expert involvement. It is solely a regulatory submission summary outlining the device's characteristics and its predicate devices.

Therefore, I cannot provide the requested information in the format specified. The document lacks the detailed study results and performance metrics needed to answer your questions.

Ask a specific question about this device